Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02683772 | Astral VAPS AutoEPAP Clinical Trial | PHASE3 | COMPLETED | 42 | — | — | Apr 15, 2016 | Jul 6, 2017 | Jul 26, 2019 | 5 | United States |
Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP
| Arm | Type | Description |
|---|---|---|
| iVAPS with AutoEPAP | EXPERIMENTAL | This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night. |
| iVAPS with manual EPAP | ACTIVE_COMPARATOR | This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night. |
| Name | Type | Description |
|---|---|---|
| Astral | DEVICE | Astral ventilator |
Inclusion criteria for the study are: 1. Participant has ability to provide written informed consent 2. Participants aged ≥18 years old 3. Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg) 4. Pa...